FDA 510(k)

LYPHOCHEK ASSAYED CHEMISTRY CONTROL

K-Number: K040273 · 2004-03-04

Decision Date2004-03-04

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

LYPHOCHEK ASSAYED CHEMISTRY CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories, Inc.. It received FDA 510(k) clearance on 2004-03-04 under 510(k) number K040273. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYPHOCHEK ASSAYED CHEMISTRY CONTROL?

LYPHOCHEK ASSAYED CHEMISTRY CONTROL is a medical device that received FDA 510(k) clearance on 2004-03-04. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K040273.

When did LYPHOCHEK ASSAYED CHEMISTRY CONTROL receive FDA 510(k) clearance?

LYPHOCHEK ASSAYED CHEMISTRY CONTROL received FDA 510(k) clearance on 2004-03-04, under 510(k) number K040273.

Who is the listed applicant for LYPHOCHEK ASSAYED CHEMISTRY CONTROL?

The FDA 510(k) record lists Bio-Rad Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LYPHOCHEK ASSAYED CHEMISTRY CONTROL?

The FDA product code for LYPHOCHEK ASSAYED CHEMISTRY CONTROL is JJY.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.